A Single-arm Pilot Study, to Assess the Efficacy of Cerebellar IMRT Combined With Cerebral SRS in Patients With Brain Metastases That Are Predominantly in the Posterior Fossa - a Novel Treatment Approach
Sponsor study identifier
interventional
37
1 country
1
Study Start
February 11, 2021
Actual (reported)Primary Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A single-arm pilot study, to assess the efficacy of cerebellar IMRT combined with cerebral SRS in patients with brain metastases that are predominantly in the posterior fossa - a novel treatment approach
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 11, 2021
Actual (reported)December 12, 2021
Actual (reported)July 28, 2022
Actual (reported)December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Brain control: Central Nervous System (CNS)- Progression Free Survival (PFS)
Metastatic brain lesions treated with IMRT/SRS will be tracked and measured using MRI. Disease in the brain and systemically will be assessed by RECIST.
Change in lesion size in the whole body will be followed and assessed at screen, 2 month after radiation treatment, then every 3 month until the date of first documented progression or date of death from any cause, up to 10 years.
Cognitive function
Change in patient cognitive function will be followed and assessed at screen, 2 month after radiation treatment, then every 3 month, until the date of first documented progression or date of death from any cause, up to 10 years.
Intensity-modulated Radiation Therapy (IMRT)/VMAT with integrated boost to the cerebellum and metastases and Stereotactic Radiosurgery (SRS) to the cerebral metastases as a novel treatment combination for brain metastases
Radiation treatment of IMRT to the cerebellum and SRS to the cerebrum
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hadassah Ein Kerem Medical Center
Jerusalem, 9112001, Israel
Gutt R, Dawson G, Cheuk AV, Fosmire H, Moghanaki D, Kelly M, Jolly S. Palliative Radiotherapy for the Management of Metastatic Cancer: Bone Metastases, Spinal Cord Compression, and Brain Metastases. Fed Pract. 2015 May;32(Suppl 4):12S-16S.
Nayak L, Lee EQ, Wen PY. Epidemiology of brain metastases. Curr Oncol Rep. 2012 Feb;14(1):48-54. doi: 10.1007/s11912-011-0203-y.
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First Submitted
December 12, 2021
First Posted
July 28, 2022
Study Start
February 11, 2021
Actual (reported)Primary Completion
December 2024
Estimated (date passed)Quality of life (QOL)
Change in patient QOL will be followed and assessed at screen, 2 month after radiation treatment, then every 3 month, until the date of first documented progression or date of death from any cause, up to 10 years.
Overall survival (OS)
Status will be checked at every visit and follow up, until the date of death from any cause, up to 10 years.
Contact the study team to confirm eligibility.
Martinez P, Mak RH, Oxnard GR. Targeted Therapy as an Alternative to Whole-Brain Radiotherapy in EGFR-Mutant or ALK-Positive Non-Small-Cell Lung Cancer With Brain Metastases. JAMA Oncol. 2017 Sep 1;3(9):1274-1275. doi: 10.1001/jamaoncol.2017.1047.
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Sahgal A, Aoyama H, Kocher M, Neupane B, Collette S, Tago M, Shaw P, Beyene J, Chang EL. Phase 3 trials of stereotactic radiosurgery with or without whole-brain radiation therapy for 1 to 4 brain metastases: individual patient data meta-analysis. Int J Radiat Oncol Biol Phys. 2015 Mar 15;91(4):710-7. doi: 10.1016/j.ijrobp.2014.10.024.
Sahgal A, Ruschin M, Ma L, Verbakel W, Larson D, Brown PD. Stereotactic radiosurgery alone for multiple brain metastases? A review of clinical and technical issues. Neuro Oncol. 2017 Apr 1;19(suppl_2):ii2-ii15. doi: 10.1093/neuonc/nox001.
Brown PD, Jaeckle K, Ballman KV, Farace E, Cerhan JH, Anderson SK, Carrero XW, Barker FG 2nd, Deming R, Burri SH, Menard C, Chung C, Stieber VW, Pollock BE, Galanis E, Buckner JC, Asher AL. Effect of Radiosurgery Alone vs Radiosurgery With Whole Brain Radiation Therapy on Cognitive Function in Patients With 1 to 3 Brain Metastases: A Randomized Clinical Trial. JAMA. 2016 Jul 26;316(4):401-409. doi: 10.1001/jama.2016.9839.
Nabors LB, Ammirati M, Bierman PJ, Brem H, Butowski N, Chamberlain MC, DeAngelis LM, Fenstermaker RA, Friedman A, Gilbert MR, Hesser D, Holdhoff M, Junck L, Lawson R, Loeffler JS, Maor MH, Moots PL, Morrison T, Mrugala MM, Newton HB, Portnow J, Raizer JJ, Recht L, Shrieve DC, Sills AK Jr, Tran D, Tran N, Vrionis FD, Wen PY, McMillian N, Ho M; National Comprehensive Cancer Network. Central nervous system cancers. J Natl Compr Canc Netw. 2013 Sep 1;11(9):1114-51. doi: 10.6004/jnccn.2013.0132.
Sahgal A. Point/Counterpoint: Stereotactic radiosurgery without whole-brain radiation for patients with a limited number of brain metastases: the current standard of care? Neuro Oncol. 2015 Jul;17(7):916-8. doi: 10.1093/neuonc/nov087. No abstract available.
Sahgal A, Larson D, Knisely J. Stereotactic radiosurgery alone for brain metastases. Lancet Oncol. 2015 Mar;16(3):249-50. doi: 10.1016/S1470-2045(14)71106-4. No abstract available.
Mohammadi AM, Recinos PF, Barnett GH, Weil RJ, Vogelbaum MA, Chao ST, Suh JH, Marko NF, Elson P, Neyman G, Angelov L. Role of Gamma Knife surgery in patients with 5 or more brain metastases. J Neurosurg. 2012 Dec;117 Suppl:5-12. doi: 10.3171/2012.8.GKS12983.
Grandhi R, Kondziolka D, Panczykowski D, Monaco EA 3rd, Kano H, Niranjan A, Flickinger JC, Lunsford LD. Stereotactic radiosurgery using the Leksell Gamma Knife Perfexion unit in the management of patients with 10 or more brain metastases. J Neurosurg. 2012 Aug;117(2):237-45. doi: 10.3171/2012.4.JNS11870. Epub 2012 May 25.
Rava P, Leonard K, Sioshansi S, Curran B, Wazer DE, Cosgrove GR, Noren G, Hepel JT. Survival among patients with 10 or more brain metastases treated with stereotactic radiosurgery. J Neurosurg. 2013 Aug;119(2):457-62. doi: 10.3171/2013.4.JNS121751. Epub 2013 May 10.
Chang WS, Kim HY, Chang JW, Park YG, Chang JH. Analysis of radiosurgical results in patients with brain metastases according to the number of brain lesions: is stereotactic radiosurgery effective for multiple brain metastases? J Neurosurg. 2010 Dec;113 Suppl:73-8. doi: 10.3171/2010.8.GKS10994.
Yamamoto M, Serizawa T, Shuto T, Akabane A, Higuchi Y, Kawagishi J, Yamanaka K, Sato Y, Jokura H, Yomo S, Nagano O, Kenai H, Moriki A, Suzuki S, Kida Y, Iwai Y, Hayashi M, Onishi H, Gondo M, Sato M, Akimitsu T, Kubo K, Kikuchi Y, Shibasaki T, Goto T, Takanashi M, Mori Y, Takakura K, Saeki N, Kunieda E, Aoyama H, Momoshima S, Tsuchiya K. Stereotactic radiosurgery for patients with multiple brain metastases (JLGK0901): a multi-institutional prospective observational study. Lancet Oncol. 2014 Apr;15(4):387-95. doi: 10.1016/S1470-2045(14)70061-0. Epub 2014 Mar 10.
Gerstenecker A, Nabors LB, Meneses K, Fiveash JB, Marson DC, Cutter G, Martin RC, Meyers CA, Triebel KL. Cognition in patients with newly diagnosed brain metastasis: profiles and implications. J Neurooncol. 2014 Oct;120(1):179-85. doi: 10.1007/s11060-014-1543-x. Epub 2014 Jul 18.
Trifiletti DM, Lee CC, Winardi W, Patel NV, Yen CP, Larner JM, Sheehan JP. Brainstem metastases treated with stereotactic radiosurgery: safety, efficacy, and dose response. J Neurooncol. 2015 Nov;125(2):385-92. doi: 10.1007/s11060-015-1927-6. Epub 2015 Sep 4.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 28, 2022
Record last verified: 2022-07
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